An interventional study of Evaluation of urinary dysfunction in patients with CANVAS in Cerebellar Ataxia, Neuropathy and Vestibular Areflexia, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Diagnostic
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Among 10 studies in Cerebellar Ataxia with a site in France — 4 open to participants now, 4 under way, none of them phase 3. Cerebellar Ataxia · France.
Among the 10 studies in Cerebellar Ataxia with a site in France, this one is the only one that started in 2025, is one of 5 with no phase, and was the 10th registered.
72 studies on the registry are indexed under Cerebellar Ataxia; 16 are open to participants now.
Browse Cerebellar Ataxia studies →4 of the 10 studies in Cerebellar Ataxia with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire Dijon · Sites in France
Healthy volunteers
University Hospital, Strasbourg, France · Sites in France
Ages 5+ · Healthy volunteers
Hospices Civils de Lyon · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 10 Cerebellar Ataxia studies recruiting now, 7 (70%) set no upper age limit and 2 (20%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 40 is above the median of 25 across 55 interventional studies indexed under Cerebellar Ataxia.
Median enrollment 48 across the 5 interventional studies, 150 across the 5 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 8 most frequent:
Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
Centre Hospitalier Universitaire de Nice has 2 studies filed under Cerebellar Ataxia — fewer than ten, so there is no comparison to draw.
2 of the studies in Cerebellar Ataxia with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06817707Centre Hospitalier Universitaire de NiceEvaluation of Urinary Dysfunction in CANVAS Patients | 2027-03 |
| NCT06089863Hospices Civils de LyonRehabilitation Program on Genetic and Degenerative Ataxia | 2027-07-01 |
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Among the 10 studies in Cerebellar Ataxia with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The investigator wishes to evaluate the prevalence of urinary symptoms in patients diagnosed with Cerebellar Ataxia, Neuropathy, Vestibular Areflexia Syndrome (CANVAS).
As much as one third of patients living with CANVAS experience symptoms of urinary system dysfunction. The primary objective of this study is to evaluate the incidence of urinary symptoms in these patients, as well as the potential complications that might occur at the level of the upper and lower urinary system. The investigator also wishes to analyse the connection between the severity of the neurological deficits, the presence of dysautonomia and the presence of urinary dysfunction. To that end, the data collected in the study will concern : a detailed neurological examination including SARA (Scale for the assessement and rating of ataxia) scale assessement, laboratory tests of the renal function, dysautonomia tests with Sudoscan and research of orthostatic hypotension, urinary function questionnaires, dysautonomia questionnaire, urodynamic tests and urinary system ultrasound.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Evaluation of urinary dysfunction in patients with CANVAS
Urinary dysfunction will be evaluated with neurologic exam, interrogation, urinary dairy report, self-questionnaires, biologic analysis, Sudoscan and urological exams
Evaluate the prevalence of urinary dysfunctions in patients with CANVAS genetically confirmed
The percentage of participants with urinary symptoms will be calculated by multiplying the number of participants with a USP (Urinary Symptom Profile) score greater than of equal to 1 by the total number of subjects included in the study, multiplied by 100. USP self-questionnaire was developped by the French Association of Urology. It aims to assess the symptoms of low urinary tract symptoms (LUTS) in men and women. It contains 13 items that assess stress urinary incontinence, bladder hyperreactivity and dysuria.
Time frame: at inclusion
Characterise the type of urinary dysfunctions
To characterize the type of urinary dysfunctions (urinary incontinence, dysuria, bladder hyperactivity (urgent or pollakiuria)), we will use the answers to the USP (Urinary Symptom Profile) self-questionnaire. USP self-questionnaire was developped by the French Association of Urology. It aims to assess the symptoms of low urinary tract symptoms (LUTS) in men and women. It contains 13 items that assess stress urinary incontinence, bladder hyperreactivity and dysuria.
Time frame: at inclusion
Characterise the severity of each type of urinary dysfunctions
To characterize the degree of severity of urinary dysfunctions (mild, moderate, severe), we will use the answers to the IPSS (International Prostate Symptom Score) self-questionnaire. This questionnaire is a screening tool, which helps with the diagnosis and monitoring of symptoms of benign prostatic hypertrophy (BPH). It consists of 7 questions on urinary difficulties and one question on quality of life. Questions include: incomplete bladder emptying, frequency of urination, intermittent urination (stop and restart), urge to urinate (feeling "urgent"), low jet, effort to urinate (force or push), nycturia. Each question refers to the last month and has a score of 1 to 5, for a total of 35 points maximum. Patients can be classified according to the severity of symptoms: from 0 to 7 = low symptomatic; 8 to 19 = moderately symptomatic; from 20 to 35 = severe symptoms.
Time frame: at inclusion
Characterise the impact of urinary dysfunctions on patient's quality of life
To characterize the impact of urinary dysfunctions on patient's quality of life, we will use the SF-Qualiveen urological self-questionnaire. This questionnaire was developed to specifically and rapidly assess the impact on quality of life of urinary disorders in patients with a neurological bladder. Its initial validation was performed in patients with multiple sclerosis. This rapid form of the Qualiveen scale has 8 items evaluating 4 domains: discomfort, constraints, fears and patient experience. Each item is rated from 0 to 4
Time frame: at inclusion
Assess the prevalence of different types of urinary dysfunctions
To calculate the prevalence of each type of urinary dysfunctions (urinary incontinence, dysuria, bladder hyperactivity (urgent or pollakiuria)), the percentage of participants with each type of impairment will be calculated as the ratio between the number of subjects in each group of impairment and the total number of participants with a USP score greater than or equal to 1, multiplied by 100.
Time frame: at inclusion
Assess the prevalence of biological complications in the upper urinary tract
To calculate the prevalence of biological complications in the upper urinary tract, the percentage of subjects with abnormal renal function at the biological balance will be calculated by the ratio of the number of subjects with glomerular filtration rate (GFR) \< 90 mL/min/1,73 m2 and the total number of participants with a USP score greater than or equal to 1, multiplied by 100.
Time frame: at inclusion
Assess the prevalence of structural complications in the upper urinary tract
To calculate the prevalence of structural complications in the upper urinary tract, the percentage of subjects with structural abnormalities of the urinary system will be calculated by the ratio of the number of subjects with pyelocalicial dilation, renal lithiasis or abnormal bladder wall on renal ultrasound and the total number of participants with a USP score greater than or equal to 1, multiplied by 100.
Time frame: within 6 months after inclusion
Assess prevalence of urinary flow malfunction
To calculate the prevalence of urinary flow malfunction, the percentage of subjects with functional urinary anomalies will be calculated by the ratio of the number of subjects with a deviation from the bladder emptying curve, or a maximum flow rate \< 15 mL at urinary flow, or a post-micturition residue greater than 100 mL and the total number of participants with USP greater than or equal to 1, multiplied by 100.
Time frame: within 6 months after inclusion
Assess prevalence of dysautonomia
To assess the prevalence of dysautonomia, the percentage of subjects with dysautonomia will be calculated by the ratio of participants with a positive Sudoscan or orthostatic hypotension test and the total number of participants, multiplied by 100.
Time frame: at inclusion
Assess the prevalence of dysautonomia symptoms
To calculate the prevalence of dysautonomia symptoms, the percentage of subjects with dysautonomia symptoms will be calculated as the ratio between the number of subjects with an abnormal response to the SCOPA-AUT (Scales for outcome in Parkinson's disease - Autonomic dysfunction) questionnaire and the total number of participants, multiplied by 100. The SCOPA-AUT is a validated scale developed to assess symptoms of dysautonomia in patients with Parkinson's disease and multisystemic atrophy. It allows to evaluate the symptoms of digestive, urinary, sexual, thermoregulatory, pupillary and cardiovascular dysfunction. It is composed of 26 questions. Each question refers to the last month and has a score of 1 to 4 or 5.
Time frame: at inclusion
Assess the relationship between urinary dysfunction and presence of dysautonomia
To assess the association between urinary dysfunction and dysautonomia, we will compare the percentage of participants with a UPS score greater than or equal to 1 among participants who have dysautonomia (following the SCOPA-AUT questionnaire, the SUDOSCAN test or the search for orthostatic hypotension), and the percentage of participants with a USP score greater than or equal to 1 among participants without dysautonomia.
Time frame: at inclusion
Assess the relationship between severity of neurological dysfunction and dysautonomia
To assess the relationship between severity of neurological dysfunction and dysautonomia, we will calculate the SARA (Scale for the assessement and rating of ataxia) score for each participant and divide patients into 3 subgroups: Group 1 (SARA score \< 15), Group 2 (SARA score between 15 - 25) and Group 3 (SARA score \> 25). The SARA score was developed to evaluate the various deficits resulting from cerebellum dysfunction. It is divided into 8 categories with a cumulative score of 0 (without ataxia) to 40 (the most severe form of ataxia): walking, standing, sitting, speaking, finger hunting, nose test - quick alternate hand movements, heel slip - ankle. For items 5 to 8, the assessment is done bilaterally and then the average value is calculated to obtain the final score. We will then calculate and compare the percentage of subjects with dysautonomia (following SCOPA AUT questionnaire, SUDOSCAN test or search for orthostatic hypotension) in each SARA score group.
Time frame: at inclusion
Assess the relationship between urinary dysfunction and severity of neurological dysfunction
To assess the relationship between urinary dysfunction and severity of neurological dysfunction, we will calculate and compare the percentage of subjects with urological symptoms or a USP score greater than or equal to 1 in each SARA score group.
Time frame: at inclusion
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.
Of 30 interventional studies with no phase under Cerebellar Ataxia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12. This study's planned 24 months is close to that.
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